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Sylvant

(Siltuximab)

Phase 3Monoclonal antibody

RRECORDATI GROUP

Siltuximab is used to treat a rare blood cancer called multicentric Castleman disease, which causes swollen lymph nodes and inflammation throughout the body.[1] Sylvant is currently being investigated across 28 indications[3], with its most advanced program in Phase 3.[1]

Sylvant is one of 671 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Phase 3.

28

Indications

31

Total Trials

9

Active Trials

670

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Non-Hodgkins LymphomaActive, not recruiting

Prostate AdenocarcinomaActive, not recruiting

Monoclonal GammopathyActive, not recruiting

Idiopathic Multicentric Castleman DiseaseUnknown

Kidney CancerActive, not recruiting

NeurotoxicityActive, not recruiting

LymphomaActive, not recruiting

Immune System DiseaseUnknown

Giant Lymph Node HyperplasiaUnknown

LeukemiaActive, not recruiting

Non-Hodgkins LymphomaPhase 2

Active, not recruiting

Prostate AdenocarcinomaPhase 1

Active, not recruiting

Monoclonal GammopathyPhase 1

Active, not recruiting

Idiopathic Multicentric Castleman DiseasePreclinical

Unknown

Kidney CancerPhase 2

Active, not recruiting

NeurotoxicityPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Immune System DiseasePreclinical

Unknown

Giant Lymph Node HyperplasiaPreclinical

Unknown

LeukemiaPhase 2

Active, not recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Sylvant

RRECORDATI GROUP

Bnt162b2

Singulair

Proventil

Mylan Pharmaceuticals Inc

Aquasol E

NNational Eye Institute (NEI)

HB-Admscs

HHope Biosciences Research Foundation

Antihypertensive Agents

NNational Heart, Lung, and Blood Institute (NHLBI)

MRNA COVID-19 Vaccine

Sivelestat Sodium

TThe First Hospital of Jilin University

Pfizer-Biontech COVID-19 Vaccine

PProvidence Therapeutics Holdings Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Multiple Myeloma

NCT03315026

Q3 2027

Phase 2Recruiting

Multiple Myeloma

NCT07106671

Q4 2027

Phase 2Recruiting

Multiple Myeloma

NCT06679829

Phase 2Recruiting

Schwannoma

NCT05684692

Phase 2Active, not recruiting

Neurotoxicity

NCT04975555

Q2 2028

Phase 1Recruiting

Lung Transplantation

NCT06990711

Clinical

Trials by Indication[1]

Multiple Myeloma8 trials

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00401843·307 enrolled

A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01309412·9 enrolled

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01484275·85 enrolled

Show 5 more trials

An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma

Completed·CCentocor, Inc.·Phase 2·NCT00402181·53 enrolled

Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03315026·30 enrolled

A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06679829·215 enrolled

Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM)

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01531998·14 enrolled

A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07106671·20 enrolled

Pancreatic Cancer1 trial

Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer

Completed·EEmory University·Phase 1/2·NCT04191421·35 enrolled

Pneumonia1 trial

Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia

Completed·JJudit Pich Martínez·Phase 2·NCT04329650·163 enrolled

Type 1 Diabetes1 trial

Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes

Completed·—·Phase 1·NCT02641522·10 enrolled

Acute Myeloblastic Leukaemia1 trial

Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM

Unknown status·NNantes University Hospital·Phase 1·NCT05697510·12 enrolled

19 more indications

Leukemia1 trial

Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT05316116·6 enrolled

Treatment1 trial

A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01400503·60 enrolled

Neurotoxicity1 trial

Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy

Active, not recruiting·UUniversity of Alabama at Birmingham·Phase 2·NCT04975555·30 enrolled

Prostate Cancer1 trial

A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Terminated·CCentocor, Inc.·Phase 2·NCT00385827·106 enrolled

COVID-191 trial

Treatment of COVID-19 Patients With Anti-interleukin Drugs

Completed·UUniversity Hospital, Ghent·Phase 3·NCT04330638·342 enrolled

Cytokine Release Syndrome1 trial

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

Withdrawn·JJack Khouri, MD·Phase 2·NCT06352866

Efficacy and Safety1 trial

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01024036·79 enrolled

Schwannoma1 trial

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Recruiting·MMassachusetts General Hospital·Phase 2·NCT05684692·40 enrolled

Immune-related Adverse Events1 trial

Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial

Recruiting·YYuanquan Yang·Phase 2·NCT06470971·40 enrolled

Castleman disease1 trial

Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease

Terminated·RRECORDATI GROUP·Phase 2·NCT04838860·22 enrolled

Monoclonal Gammopathy1 trial

A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01219010·30 enrolled

ARDS1 trial

SILtuximab in Viral ARds (SILVAR) Study

Terminated·RRECORDATI GROUP·Phase 3·NCT04616586·555 enrolled

Myelodysplastic Syndrome1 trial

A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01513317·76 enrolled

Essential Thrombocythemia1 trial

Siltuximab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis

Withdrawn·NNorthwestern University·Phase 1·NCT02805868

Lymphoma1 trial

Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma

Completed·TTimothy Voorhees·Phase 1·NCT05665725·11 enrolled

Schizophrenia1 trial

Siltuximab in Schizophrenia

Unknown status·BBrian Miller·Phase 1/2·NCT02796859·30 enrolled

Lung Transplantation1 trial

A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation

Recruiting·WWashington University School of Medicine·Phase 1·NCT06990711·30 enrolled

B-cell acute lymphoblastic leukemia1 trial

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07570173·340 enrolled

Non-Hodgkin Lymphoma1 trial

Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab

Recruiting·TTaylor Brooks·Phase 1·NCT06447376·20 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 23, 2014

SYLVANT

BLA BLA125496

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Siltuximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Siltuximab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Siltuximab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125496). U.S. Food & Drug Administration.
[5]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-6 Antagonist[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: RRECORDATI GROUP

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